New data reinforces the efficacy and safety profile of cannabis in Multiple Sclerosis Spasticity

London, UK; 2 October 2013: GW Pharmaceuticals plc (AIM: GWP, Nasdaq: GWPH, “GW”) announced that data from new MS spasticity studies (clinical trial data, observational study data and registries data collection) is being presented today at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark. The following press release was issued today by GW’s commercial partner, Almirall S.A., regarding the data presentation:

Copenhagen, Denmark, 2nd October 2013: Almirall S.A. (ALM) today announces the latest evidence with Sativex® (THC:CBD spray) from new MS spasticity studies (clinical trial data, observational study data and registries data collection). These data, presented today at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark, show that Sativex® effectiveness is maintained long term with no additional safety concerns identified in clinical practice.

Two-thirds of the more than 2,000 patients with MS surveyed in the recent Spanish “6E” study reported a certain degree of spasticity, being moderate or severe in 40% of them[i].

“Sativex can improve the spasticity symptoms impairment of MS patients without affecting such issues as driving ability, cognition or mood”, says Dr. Tiina Rekand, of the Haukeland University Hospital Bergen, Norway.

Most patients with MS experience a degree of spasticity which is associated with increasing disability and therefore rising healthcare costs. Spasticity has a negative impact on those patients’ quality of life as it reduces their capacity to carry out everyday activities, as well as having an impact on the already impaired general mobility, bladder function, fatigue and quality of sleep.

“Sativex® provides symptomatic treatment of MS spasticity in patients who have not responded to other medicines. It has proven to reduce significantly patients’ rigidity and spasms frequency leading to an improved sleep quality and better performing of daily activities. This means greater independence for patients, requiring less help from family members or carers”, add Dr. Carlo Pozzilli, of the Multiple Sclerosis Centre Sant’ Andrea Hospital, Rome, Italy.

The lack of effects on patient cognition and mood from Sativex are some of the new data presented at the ECTRIMS 2013 congress. A double-blind, randomised, placebo-controlled Phase IV study was carried out in MS specialised EU centres. After 50 weeks of treatment with Sativex spray, (mean dose 6.4 sprays/day) findings demonstrated equivalence to placebo stable status both in cognition and mood scales. The improvements in spasticity were confirmed by more than 70% of patients (Global impression of change (GIC)), but also by physicians and carers, always significantly different to the placebo treated group. Treatment with Sativex® was generally well tolerated.

Another new study, which was prospective and observational, conducted in three German centres during the first four to six Sativex treatment weeks (mean dose 5.2 sprays/day), showed no adverse effects on driving ability (no significant changes vs. baseline in a battery of computerized tests)). The MS spasticity and spasms count improved and the treatment was again well tolerated.

Sativex UK, Germany and Spain registries have recruited approximately 700 patients to date without signals of new tolerability/safety concerns (falls, addiction, etc.) and over 20,000 patient/years of use are estimated without any relevant pharmacovigilance issues.

Recent guidelines, such as the German DGN 2012, recommend a role for THC:CBD spray in the management of MS spasticity.

Prof. Koehler presented his large German centre experience with Sativex® in everyday clinical practice.

“Sativex has become a useful tool for relieving the problems of resistant to previous medication MS spasticity patients, acting on relevant quality of life impairments or marked associated symptoms such as pain, sleep disruptions or bladder dysfunction”, says Prof. Koehler’s, of the Prof. J. Köhler, Marianne Strauss Clinic, Berg, Germany.

In Europe, Sativex® is commercialized for the treatment of MS spasticity in the UK, Spain, Germany, Denmark, Norway, Italy, Poland and Sweden. Launches are also currently in preparation in Switzerland, Austria, Iceland, Finland and other countries. In addition, regulatory authorization has been received in Belgium, the Netherlands, Portugal, Czech Republic and Slovakia with launches expected from the end of 2013 onwards.

In addition to MS spasticity, Sativex®, is also being developed by GW Pharmaceuticals, for the treatment of cancer pain. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom) and Mexico.